Energy Expenditure and Gastric Bypass Surgery Study

NCT00671957 | Completed DMC

• 1 other identifier: IRB00002212
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess whether the energy you burn daily increases after you have bariatric surgery. Until now, there hasn't been an effective way of measuring all activity on a daily basis. Physical Activity Monitoring System (PAMS) has been created just for this purpose. PAMS is a garment that can be worn under your clothes, that records body position and movement through space. We will use the PAMS along with special water to measure your total daily energy expenditure right before surgery, and again 6 months and 24 months after surgery. Study subjects will be initially recruited from OHSU IRB-Approved advertisements. Interested study subjects will be screened through an informal telephone interview. If there are no health conditions that exclude participation, subjects will be asked to give IRB-approved consent. Subjects will be consenting to undergo three 18 day phases. Each phase will consist of 15 daily visits to the Clinical \& Translational Research Center (CTRC), and 3 full day and nights in the CTRC.

Conditions

Morbid Obesity

Keywords

Obesity; Bariatric; Surgery; Activity

Outcome Measures

Primary Outcomes (1)

• To compare physical activity and activity thermogenesis in patients undergoing gastric bypass bariatric surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery.

  To compare physical activity and activity thermogenesis in patients undergoing gastric bypass bariatric surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery.

  24 months

Secondary Outcomes (2)

• To evaluate whether changes in weight correlate with changes in activity thermogenesis in patients undergoing gastric bypass surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery.

  24 months

• To evaluate the changes in basal metabolic rate (BMR) and thermic effect of food (TEF) in patients undergoing gastric bypass surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery.

  24 months

Study Arms (1)

Patients undergoing gastric bypass

Patients undergoing gastric bypass surgery and who are participants in Longitudinal Assessment of Bariatric Surgery (LABS-2). Inclusion Criteria: * No acute illnesses * Weight less than 227 kg (limit of Bod Pod and Treadmill) * Able to walk at 2.4 mph for 15 minutes (needed for the energy expenditure testing) * No tobacco use * Ability to stop alcohol consumption during test phases * For female subjects; no plans for pregnancy in 24 months and menstrual cycles of 21-35 days * No history of eating disorder * No history of current substance abuse * No history of chest pain or shortness of breath at rest or on exertion. * Negative pregnancy in women.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Morbidly obese patients undergoing Bariatric surgery.

You may qualify if:

• No acute illnesses
• Weight less than 227 kg (limit of Bod Pod and Treadmill)
• Able to walk at 2.4 mph for 15 minutes (needed for the energy expenditure testing)
• No tobacco use
• Ability to stop alcohol consumption during test phases
• For female subjects; no plans for pregnancy in 24 months and menstrual cycles of 21-35 days
• No history of eating disorder
• No history of current substance abuse
• No history of chest pain or shortness of breath at rest or on exertion.
• Negative pregnancy in women.

You may not qualify if:

• Informed consent not obtained
• Prior bariatric surgery
• Unlikely to comply with follow-up protocol (e.g., travel time from home too long to make visits feasible, unwilling to return for follow-up visits)
• Unable to communicate with local study staff
• Lactating women

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Mayo Clinic: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Bruce M Wolfe, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: February 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: June 1, 2019
• Last Updated: June 21, 2019

Record last verified: 2019-06

Locations

US (1)